TITLE 16             OCCUPATIONAL AND PROFESSIONAL LICENSING

CHAPTER 19     PHARMACISTS

PART 26               PHARMACIST PRESCRIPTIVE AUTHORITY

 

16.19.26.1             ISSUING AGENCY:  Regulation and Licensing Department - Board of Pharmacy, Albuquerque, NM.

[16.19.26.1 NMAC - N, 12-15-02; A, 03-07-11]

 

16.19.26.2             SCOPE:  All pharmacists that intend to exercise the authority to prescribe dangerous drugs based on written protocols approved by the Board.

[16.19.26.2 NMAC - N, 12-15-02]

 

16.19.26.3             STATUTORY AUTHORITY:  Section 61-11-6.A.(1) NMSA 1978 authorizes the Board of Pharmacy to adopt, regularly review and revise rules and regulations necessary to carry out the provisions of the Pharmacy Act.  Section 61-11-6.A.(7) gives the Board authority to enforce the provisions of all laws of the state pertaining to the distribution of drugs.  Under the Pharmacist Prescriptive Authority Act, Sections 61-11B-1 to 61-11B-3 NMSA 1978, the Board is required to establish regulations governing certification as a pharmacist clinician.  Section 61-11-6.A.(19) authorizes the Board to adopt rules and protocols for the prescribing of dangerous drug therapy.

[16.19.26.3 NMAC - N, 12-15-02]

 

16.19.26.4             DURATION:  Permanent.

[16.19.26.4 NMAC - N, 12-15-02]

 

16.19.26.5             EFFECTIVE DATE:  12-15-02, unless a later date is cited at the end of a section.

[16.19.26.5 NMAC - N, 12-15-02]

 

16.19.26.6             OBJECTIVE:  The objective of Part 26 of Chapter 19 is to protect the health and safety of New Mexico citizens by regulating the prescriptive authority of pharmacists.

[16.19.26.6 NMAC - N, 12-15-02]

 

16.19.26.7             DEFINITIONS:

                A.            "Antigen" means a substance recognized by the body as being foreign; it results in the production of specific antibodies directed against it.

                B.            "Antibody" means a protein in the blood that is produced in response to stimulation by a specific antigen.

                C.            "Immunization" means the act of inducing antibody formation, thus leading to immunity.

                D.            "Vaccine" means a specially prepared antigen, which upon administration to a person, will result in immunity.

                E.            "Vaccination" means the administration of any antigen in order to induce immunity; is not synonymous with immunization since vaccination does not imply success.

                F.            "Written protocol" means a physician's order, standing delegation order, or other order or protocol as defined by rule of the New Mexico board of pharmacy.

                G.            “Emergency contraception drug therapy" means the use of a drug to prevent pregnancy after intercourse.

                H.            “Tobacco cessation drug therapy” means the use of therapies, which may include drugs to assist in quitting any form of tobacco use.

[16.19.26.7 NMAC - N, 12-15-02; A, 07-15-04]

 

16.19.26.8             REFERRAL:  Any pharmacist not certified to provide a prescriptive authority service is required to refer patients to a pharmacist or other provider who provides such a service.

[16.19.26.8 NMAC - N, 12-15-02; 16.19.26.8 NMAC - N, 07-15-04]

 

16.19.26.9             VACCINES:

                A.            PROTOCOL:

                    (1)     Prescriptive authority for vaccines shall be exercised solely in accordance with the written protocol for vaccine prescriptive authority approved by the board.

                    (2)     Any pharmacist exercising prescriptive authority for vaccines must maintain a current copy of the protocol for vaccine prescriptive authority approved by the board.

                B.            EDUCATION AND TRAINING:

                    (1)     The pharmacist must successfully complete a course of training, accredited by the accreditation council for pharmacy education (ACPE), provided by:  a) the centers for disease control and prevention (CDC); or b) a similar health authority or professional body approved by the board.

                    (2)     Training must include study materials, hands-on training and techniques for administering vaccines, comply with current CDC guidelines, and provide instruction and experiential training in the following content areas:

                              (a)     mechanisms of action for vaccines, contraindication, drug interaction, and monitoring after vaccine administration;

                              (b)     standards for pediatric, adolescent, and adult immunization practices;

                              (c)     basic immunology and vaccine protection;

                              (d)     vaccine-preventable diseases;

                              (e)     recommended pediatric, adolescent, and adult immunization schedule;

                              (f)     vaccine storage management;

                              (g)     biohazard waste disposal and sterile techniques;

                              (h)     informed consent;

                              (i)     physiology and techniques for vaccine administration;

                              (j)     pre and post-vaccine assessment and counseling;

                              (k)     immunization record management;

                              (l)     management of adverse events, including identification, appropriate response, documentation and reporting;

                              (m)     reimbursement procedures and vaccine coverage by federal, state and local entities.

                    (3)     Continuing education:  Any pharmacist exercising prescriptive authority for vaccines shall complete a minimum of 0.2 CEU of live ACPE approved vaccine related continuing education every two years.  Such continuing education shall be in addition to requirements in 16.19.4.10 NMAC.

                C.            AUTHORIZED DRUGS:

                    (1)     Prescriptive authority shall be limited to those drugs and vaccines delineated in the written protocol for vaccine prescriptive authority approved by the board, and;

                    (2)     Other vaccines as determined by the CDC, the advisory committee on immunization practices (ACIP) or New Mexico department of health that may be required to protect the public health and safety

                D.            RECORDS:

                    (1)     The prescribing pharmacist must generate a written or electronic prescription for any dangerous drug authorized.

                    (2)     Informed consent must be documented in accordance with the written protocol for vaccine prescriptive authority approved by the board and a record of such consent maintained in the pharmacy for a period of at least three years.

                E.            NOTIFICATION:  Upon signed consent of the patient or guardian the pharmacist shall:

                    (1)     notify the New Mexico department of health immunization program and the patient’s designated physician or primary care provider or;

                    (2)     update the New Mexico department of health immunization program’s electronic database (NMSIIS) of any vaccine administered.

[16.19.26.9 NMAC - N, 12-15-02; 16.19.26.9 NMAC - Rn, 16.19.26.8 NMAC & A, 07-15-04; A, 01-31-07]

 

16.19.26.10          EMERGENCY CONTRACEPTION DRUG THERAPY:

                A.            PROTOCOL:

                    (1)     Prescriptive authority for emergency contraception drug therapy shall be exercised solely in accordance with the written protocol for emergency contraception drug therapy approved by the board.

                    (2)     Any pharmacist exercising prescriptive authority for emergency contraception drug therapy must maintain a current copy of the written protocol for emergency contraception drug therapy approved by the board.

                B.            EDUCATION AND TRAINING:

                    (1)     The pharmacist must successfully complete a course of training, accredited by  the accreditation council for pharmacy education (ACPE), in the subject area of emergency contraception drug therapy provided by:  a) the department of health; or b) planned parenthood or c)  a similar health authority or professional body approved by the board.

                    (2)     Training must include study materials and instruction in the following content areas:

                              (a)     mechanisms of action, contraindication, drug interaction, and monitoring of emergency contraception drug therapy;

                              (b)     current standards for prescribing emergency contraception drug therapy;

                              (c)     identifying indications for the use of emergency contraception drug therapy;

                              (d)     interviewing patient to establish need for emergency contraception drug therapy;

                              (e)     counseling patient regarding the safety, efficacy and potential adverse effects of drug products for emergency contraception;

                              (f)     evaluating patient's medical profile for drug interaction;

                              (g)     referring patient follow-up care with primary healthcare provider;

                              (h)     informed consent;

                              (i)     record management;

                              (j)     management of adverse events, including identification, appropriate response, documentation and reporting.

                    (3)     Continuing education:  Any pharmacist exercising prescriptive authority for emergency contraception drug therapy shall complete a minimum of 0.2 CEU of live ACPE approved emergency contraception drug therapy related continuing education every two years.  Such continuing education shall be in addition to requirements in 16.19.4.10 NMAC.

                C.            AUTHORIZED DRUGS:

                    (1)     Prescriptive authority shall be limited to emergency contraception drug therapy and shall exclude any device intended to prevent pregnancy after intercourse.

                    (2)     Prescriptive authority for emergency contraception drug therapy shall be limited to those drugs delineated in the written protocol for emergency contraception drug therapy approved by the board.

                D.            RECORDS:

                    (1)     The prescribing pharmacist must generate a written or electronic prescription for any dangerous drug authorized.

                    (2)     Informed consent must be documented in accordance with the approved protocol for emergency contraception drug therapy and a record of such consent maintained in the pharmacy for a period of at least three years.

                E.            NOTIFICATION:  Upon signed consent of the patient or guardian, the pharmacist shall notify the patient's designated physician or primary care provider of emergency contraception drug therapy prescribed.

[16.19.26.10 NMAC - N, 12-15-02; 16.19.26.10 NMAC - Rn, 16.19.26.9 NMAC & A, 07-15-04]

 

16.19.26.11          TOBACCO CESSATION DRUG THERAPY:

                A.            PROTOCOL:

                    (1)     Prescriptive authority for tobacco cessation drug therapy shall be exercised solely in accordance with the written protocol for tobacco cessation drug therapy approved by the board.

                    (2)     Any pharmacist exercising prescriptive authority for tobacco cessation drug therapy must maintain a current copy of the written protocol for tobacco cessation drug therapy approved by the board.

                B.            EDUCATION AND TRAINING:

                    (1)     The pharmacist must successfully complete a course of training, accredited by the accreditation council for pharmacy education (ACPE), in the subject area of tobacco cessation drug therapy provided by:  a) the department of health; or b) health and human services or c) a similar health authority or professional body approved by the board.

                    (2)     Training must include study materials and instruction in the following content areas:

                              (a)     mechanisms of action for contraindications, drug interactions, and monitoring cessation;

                              (b)     current standards for prescribing tobacco cessation drug therapy;

                              (c)     identifying indications for the use of tobacco cessation drug therapy;

                              (d)     interviewing patient to establish need for tobacco cessation drug therapy;

                              (e)     counseling patient regarding the safety, efficacy and potential adverse effects of drug products for tobacco cessation;

                              (f)     evaluating patient's medical profile for drug interaction;

                              (g)     referring patient follow-up care with primary healthcare provider;

                              (h)     informed consent;

                              (i)     record management;

                              (j)     management of adverse events, including identification, appropriate response, documentation and reporting;

                              (k)     reimbursement procedures and tobacco cessation drug therapy and education coverage by federal, state and local entities.

                    (3)     Continuing education:  Any pharmacist exercising prescriptive authority for tobacco cessation drug therapy shall complete a minimum of 0.2 CEU of live ACPE approved tobacco cessation drug therapy related continuing education every two years.  Such continuing education shall be in addition to requirements in 16.19.4.10 NMAC.

                C.            AUTHORIZED DRUGS:

                    (1)     Prescriptive authority shall be limited to tobacco cessation drug therapy including prescription and non-prescription therapies.

                    (2)     Prescriptive authority for tobacco cessation drug therapy shall be limited to those drugs delineated in the written protocol approved by the board.

                D.            RECORDS:

                    (1)     The prescribing pharmacist must generate a written or electronic prescription for any dangerous drug authorized.

                    (2)     Informed consent must be documented in accordance with the approved protocol for tobacco cessation drug therapy and a record of such consent maintained in the pharmacy for a period of at least three years.

                E.            NOTIFICATION:  Upon signed consent of the patient, the pharmacist shall notify the patient's designated physician or primary care provider of tobacco cessation drug therapy prescribed.

[16.19.26.11 NMAC - N, 07-15-04]

 

16.19.26.12          TB TESTING:

                A.            PROTOCOL:

                    (1)     Prescriptive authority for Tuberculosis (TB) testing shall be exercised solely in accordance with the written protocol for TB testing drug therapy approved by the board.

                    (2)     Any pharmacist exercising prescriptive authority for TB testing must maintain a current copy of the written protocol for TB testing approved by the board.

                B.            EDUCATION AND TRAINING:

                    (1)     The pharmacist must successfully complete training as specified by the centers for disease control.

                    (2)     Continuing education:  Any pharmacist exercising prescriptive authority for TB testing shall complete continuing education as specified by the centers for disease control.

                C.            AUTHORIZED DRUGS:

                    (1)     TB skin antigen serum(s).

                    (2)     Prescriptive authority for TB testing shall be limited to those drugs delineated in the written protocol approved by the board.

                D.            RECORDS:

                    (1)     The prescribing pharmacist must generate a written or electronic prescription fro any TB test administered.

                    (2)     Informed consent must be documented in accordance with the approved protocol for TB testing and a record of such consent maintained in the pharmacy for a period of at least three years.

                E.            NOTIFICATION: Upon signed consent of the patient, the pharmacist shall notify the patient’s designated physician or primary care provider and the department of health of any positive TB test.

[16.19.26.12 NMAC - N, 03-07-11]

 

16.19.26.13          NALOXONE FOR OPIOID OVERDOSE:

                A.            PROTOCOL:

                    (1)     Prescriptive authority for naloxone drug therapy shall be exercised solely in accordance with the written protocol for naloxone drug therapy approved by the board.

                    (2)     Any pharmacist exercising prescriptive authority for naloxone drug therapy must maintain a current copy of the written protocol for naloxone drug therapy approved by the board.

                B.            EDUCATION AND TRAINING:

                    (1)     The pharmacist must successfully complete a course of training, accredited by the accreditation council for pharmacy education (ACPE), in the subject area of naloxone for opioid overdose drug therapy provided by:

                              (a)     the New Mexico pharmacists association; or

                              (b)     a similar health authority or professional body approved by the board.

                    (2)     Training must include study materials and instruction in the following content areas:

                              (a)     mechanisms of action;

                              (b)     contraindications;

                              (c)     identifying indications for the use of naloxone drug therapy;

                              (d)     patient screening criteria;

                              (e)     counseling and training patient and care-giver regarding the safety, efficacy and potential adverse effects of naloxone;

                              (f)     evaluating patient's medical profile for drug interactions;

                              (g)     referring patient for follow-up care with primary healthcare provider;

                              (h)     informed consent;

                              (i)     record management;

                              (j)     management of adverse events.

                    (3)     Continuing education: Any pharmacist exercising prescriptive authority for naloxone drug therapy shall complete a minimum of 0.2 CEU of live ACPE approved naloxone drug therapy related continuing education every two years. Such continuing education shall be in addition to requirements in 16.19.4.10 NMAC.

                C.            AUTHORIZED DRUG(S):

                    (1)     Prescriptive authority shall be limited to naloxone and shall include any device(s) approved for the administration of naloxone.

                    (2)     Prescriptive authority for naloxone drug therapy shall be limited to naloxone as delineated in the written protocol for naloxone drug therapy approved by the board.

                D.            RECORDS:

                    (1)     The prescribing pharmacist must generate a written or electronic prescription for any naloxone dispensed.

                    (2)     Informed consent must be documented in accordance with the approved protocol for naloxone drug therapy and a record of such consent maintained in the pharmacy for a period of at least three years.

                E.            NOTIFICATION:  Upon signed consent of the patient, the pharmacist shall notify the patient's designated physician or primary care provider within 15 days of naloxone dispensing.

[16.19.26.13 NMAC - N, 03-14-14]

 

HISTORY OF 16.19.26 NMAC:  [RESERVED]